Phase 2
N=135
A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00422461 ↗Enrolled (actual)
135
Serious AEs
1.5%
Results posted
Oct 2021
Primary outcome: Primary: Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28 — 1.38; -1.42; -3.28; -5.59 millimeter of mercury — p=0.0822
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- placebo (Drug); PF-00489791 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28 |
1.38; -1.42; -3.28; -5.59 | 0.0822 |
| SECONDARY Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) as Measured by ABPM at Day 28 |
0.73; -1.97; -3.83; -6.23 | 0.0264 sig |
| SECONDARY Change From Baseline in Mean 24-Hour SBP and DBP as Measured by ABPM at Day 28 |
-0.53; -0.40; -5.28; -3.96; -0.13; -1.58 | 0.9479 |
| SECONDARY Minimum and Maximum SBP and DBP as Measured by ABPM Over 24 Hours on Baseline, Day 1, 14 and 28 |
176.65; 179.68; 184.58; 177.45; 173.13; 176.67 | — |
| SECONDARY Change From Baseline in Cuff SBP and DBP at Day 28 |
-4.60; -5.20; -4.97; -9.76; -1.33; -4.37 | 0.8091 |
| SECONDARY Change From Baseline in Cuff SBP and DBP at Day 31 |
0.4; -0.6; -0.3; 0.4; -0.7; -0.2 | — |
| SECONDARY Change From Baseline in Cuff Mean Arterial Pressure (MAP) at Day 28 |
-2.59; -4.54; -5.53; -7.06 | 0.2567 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
12; 11; 11; 13; 1; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
10; 9; 11; 10 | — |
| SECONDARY Change From Baseline in Heart Rate at Baseline, Day 1, 7, 14, 21, 28 and 31 |
71.5; 69.2; 67.9; 68.3; 0.5; 1.8 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings |
1; 0; 0; 0 | — |
Summary
The purpose of this study is to evaluate the safety and blood pressure lowering effect of different doses of PF-00489791 in patients with mild to moderate high blood pressure
Eligibility Criteria
Inclusion Criteria
- Males and/or Females of non-childbearing potential between 18 and 70 years of age
- History of mild to moderate hypertension
Exclusion Criteria
- Type 1 or 2 diabetes on prescribed medications
- Secondary, severe, or malignant hypertension
- History of a significant cardiovascular event within the last 12 months of enrollment
Data sourced from ClinicalTrials.gov (NCT00422461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.